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Ingenol mebutate dose escalation in Actinic Keratosis
NCT01820260Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2013
- Primary completion
- Aug 2014
- Countries
- 1
- Sponsor
- LEO Pharma
- Modality
- Peptides, Small Molecules
- Drugs
- ingenol mebutate
- Conditions
- actinic keratosis (AK)
01
Overview
Phase 2, randomised, double-blind trial of ingenol mebutate in actinic keratosis (AK) (14 arms), sponsored by LEO Pharma. Primary endpoints: Maximum Tolerated Dose at 8 days and Complete Clearance of AKs at 8 weeks. Started Apr 2013; status: completed.
02
Design
14 arms- Study design
- RandomizedDouble-blind
Part 1A: 0.005% (3d)
Ingenol mebutate 0.005% for 3 days
Part 1A: 0.008% (3d)
Ingenol mebutate 0.008% for 3 days
Part 1A: 0.012% (3d)
Ingenol mebutate 0.012% for 3 days
Part 1A: 0.018% (3d)
Ingenol mebutate 0.018% for 3 days
Part 1A: 0.027% (3d)
Ingenol mebutate 0.027% for 3 days
Part 1A: 0.04% (3d)
Ingenol mebutate 0.04% for 3 days
8 more in the full profile.
03
Endpoints
Primary
Maximum Tolerated Dose
Complete Clearance of AKs
Secondary
Reduction in AK Count
Partial Clearance of AKs
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